Evaluating patient preference for dropless versus drops after cataract surgery

A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery

This study is testing whether a new eye insert can help people with cataract surgery feel better and have less pain compared to using eye drops.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years to 100 Years
• Sex: All
• Sponsor: Ophthalmic Consultants of Long Island (Academic / other)
• Locations: 1 site (Garden City, New York)
• Trial ID: NCT04205916 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of Dextenza, an intracanalicular dexamethasone insert, in managing post-operative ocular pain and inflammation compared to standard topical therapies in patients undergoing bilateral cataract surgery. Participants will be randomly assigned to receive either the experimental treatment or the control treatment for their first eye, with the second eye receiving the alternate treatment two weeks later. The study will involve a total of 100 eyes from 50 subjects, allowing for a direct comparison of patient preferences and outcomes between the two approaches.

Who should consider this trial

Good fit: Ideal candidates are healthy adults over 22 years old scheduled for bilateral cataract surgery.

Not a fit: Patients with a history of complications or adverse events related to the nasolacrimal system may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient treatment option for managing post-operative pain and inflammation in cataract surgery patients.

How similar studies have performed: Other studies have shown promising results with similar dropless approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit
* A subject must be willing and able to sign informed consent
* A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.
* A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
* A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned

Exclusion Criteria:

* A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
* A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
* A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye
* A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted
* A subject with any moderate to severe lid, conjunctival or corneal findings in either eye at the screening visit
* A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
* A subject with a known sensitivity to any of the study medications; A subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article
* A subject with a history as a steroid responder
* A subject with capsule or zonular abnormalities with preoperative lens tilt and/or decentration (e.g., Marfan's syndrome), or may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* A subject has a history of ocular trauma in their scheduled surgical eye
* A subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening
* A subject with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) in their scheduled surgical eye.
* A subject with a corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) in their scheduled surgical eye
* A subject with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in their scheduled surgical eye
* A subject with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp exam
* A subject that has been wearing Poly Methyl Metharcylate (PMMA) lenses within 6 months, gas permeable lenses within one month, or extended-wear or daily soft contact lens within 7 days of their scheduled surgery
* A subject with an inability to achieve keratometric stability for contact lens wearers
* A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
* A subject with uncontrolled glaucoma
* A subject that requires an Limbal Relaxing Incision (LRI) or AI procedure before, during or after cataract surgery
* A subject that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period
* A subject that requires the use of systemic or ophthalmic Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroid medications during the study period.
* A subject that requires the use of system or ocular medications that may affect vision, ocular inflammation or pain
* A subject with an acute or chronic disease, or illness, that would increase risk or confound study results (e.g., autoimmune disease, connective tissue disease, immunocompromised, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.)
* A subject with an uncontrolled systemic disease: A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
* A subject with diabetes that is poorly controlled
* A subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.

Intra-Operative Exclusion Criteria (Surgical Complications):

* Sulcus-sulcus or bag-sulcus fixation
* Posterior capsular rupture or zonular dialysis
* Disruption of anterior hyaloids face
* Vitreous loss
* Capsulorhexis tear
* Floppy iris syndrome
* Requirement for the use of trypan blue, capsular tension ring or other intraocular device other than the Intra ocular lens (IOL)
* Inability to place IOL in capsular bag
* Significant anterior chamber hyphema
* Zonular rupture.

Where this trial is running

Garden City, New York

• Ophthalmic Consultants of Long Island — Garden City, New York, United States (Recruiting)

Study contacts

• Principal investigator: Eric Donnenfeld, MD — Physician
• Study coordinator: Erin Loweree

Conditions Patient Preference